AQUABPLUS, B2, HF 2000 KIT

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO SAMPLES WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER PHOTOGRAPHS OF THE SAMPLE WERE PROVIDED. THE MANUFACTURER CONFIRMED THE REPORTED EVENT BASED ON THE PROVIDED INFORMATION AND PHOTOGRAPHS. THE COMPLAINT INVESTIGATION DETERMINED THAT THE LIKELY CAUSE OF THE THERMAL DAMAGE WAS A LOOSE ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH. IN SUCH AN INSTANCE THE PUMP WILL RUN ONLY WITH TWO LINE CONDUCTORS, RESULTING IN HIGHER CURRENT AND HIGHER THERMAL ENERGY. THE CABLE LUGS AT THE MOTOR PROTECTION SWITCH CAN GET OVERHEATED AND DISCOLORED BY THE RELEASED THERMAL ENERGY AT THE BAD ELECTRICAL CONTACT. THIS IS A KNOWN FAILURE. CORRECTIVE ACTIONS HAVE BEEN DEFINED AND IMPLEMENTED FOR THIS KNOWN FAILURE. THE WIRING WAS REDESIGNED AND RELEASED. THE DEVICE WAS BUILT BEFORE THE IMPROVEMENT OF THE DESIGN. IN THIS INSTANCE THE SWITCH AND CONNECTED WIRING WERE REPLACED TO RESOLVE THE REPORTED ISSUE. IT IS RECOMMENDED, IF NOT ALREADY DONE, TO REPLACE THE MOTOR PROTECTION SWITCH AND BLACK CONNECTION WIRES AGAINST THE IMPROVED DESIGN IN STAGE 1 AND STAGE 2.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DAMAGE WAS DISCOVERED ON THE MOTOR PROTECTION SWITCH, POWER CORD CABLE, AND CONNECTED BLACK CABLE WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE THERMAL DAMAGE WAS NOTED DURING MACHINE REPAIR. THE BIOMED INITIALLY CONTACTED FRESENIUS FOR TROUBLESHOOTING ASSISTANCE WHEN THERE WAS NO POWER TO STAGE 1. THE MOTOR PROTECTION SWITCH (MPS) WAS DETERMINED TO BE FAULTY. THE LINE VOLTAGE WAS CONFIRMED TO BE 212 VOLTS BETWEEN L1, L2, AND L3 AND IT WAS DETERMINED THAT AN IMPROPER LOAD VOLTAGE WAS PRESENT. THERMAL DAMAGE WAS NOTED TO THE LOAD SIDE OF THE SWITCH. THE BIOMED WAS ADVISED TO THE REPLACE THE MPS AND CONNECTED WIRING. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH A SECOND USER FACILITY BIOMED. THE BIOMED CONFIRMED THAT THE MOTOR PROTECTION SWITCH, POWER CORD CABLE, AND BLACK CABLE WERE BURNED. THE CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE A LOOSE CONNECTION AT THE MOTOR PROTECTION SWITCH CABLE. THERE WERE NO ALARMS RECEIVED. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING. THE SYSTEM WAS IN SUPPLY MODE AT THE TIME OF THE REPORTED OCCURRENCE. THE THERMAL OVERLOAD RELAY DID NOT TRIP. A BLOWN 20A FUSE WAS NOTED. THERE WERE NO POWER GRID ISSUES OR STORMS ON THE REPORTED EVENT DATE. THE SYSTEM IS PLUGGED INTO ITS OWN BREAKER. THE MOTOR PROTECTION SWITCH WAS REPLACED, THE POWER CORD CABLE WAS RE-WIRED, AND THE BLACK CABLE HEAD RECEIVED A NEW ADAPTER TO RESOLVE THE REPORTED ISSUE. THE MACHINE IS BACK IN SERVICE. THERE WAS NO REPORTED PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE.

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DAMAGE WAS DISCOVERED ON THE MOTOR PROTECTION SWITCH, POWER CORD CABLE, AND CONNECTED BLACK CABLE WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE THERMAL DAMAGE WAS NOTED DURING MACHINE REPAIR. THE BIOMED INITIALLY CONTACTED FRESENIUS FOR TROUBLESHOOTING ASSISTANCE WHEN THERE WAS NO POWER TO STAGE 1. THE MOTOR PROTECTION SWITCH (MPS) WAS DETERMINED TO BE FAULTY. THE LINE VOLTAGE WAS CONFIRMED TO BE 212 VOLTS BETWEEN L1, L2, AND L3 AND IT WAS DETERMINED THAT AN IMPROPER LOAD VOLTAGE WAS PRESENT. THERMAL DAMAGE WAS NOTED TO THE LOAD SIDE OF THE SWITCH. THE BIOMED WAS ADVISED TO THE REPLACE THE MPS AND CONNECTED WIRING. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH A SECOND USER FACILITY BIOMED. THE BIOMED CONFIRMED THAT THE MOTOR PROTECTION SWITCH, POWER CORD CABLE, AND BLACK CABLE WERE BURNED. THE CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE A LOOSE CONNECTION AT THE MOTOR PROTECTION SWITCH CABLE. THERE WERE NO ALARMS RECEIVED. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING. THE SYSTEM WAS IN SUPPLY MODE AT THE TIME OF THE REPORTED OCCURRENCE. THE THERMAL OVERLOAD RELAY DID NOT TRIP. A BLOWN 20A FUSE WAS NOTED. THERE WERE NO POWER GRID ISSUES OR STORMS ON THE REPORTED EVENT DATE. THE SYSTEM IS PLUGGED INTO ITS OWN BREAKER. THE MOTOR PROTECTION SWITCH WAS REPLACED, THE POWER CORD CABLE WAS RE-WIRED, AND THE BLACK CABLE HEAD RECEIVED A NEW ADAPTER TO RESOLVE THE REPORTED ISSUE. THE MACHINE IS BACK IN SERVICE. THERE WAS NO REPORTED PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE.